(90 days)
PMS (Mode 1~8)
It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.
TENS (Mode 9~25)
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.
Electronic Muscle Stimulator is a portable and adapter powered multifunctional device, offering both Transcutaneous Electronic Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) qualities.
Electronic Muscle Stimulator has 25 operation modes, which can give certain electrical pulse through 4 pcs of electrode pads placed on the skin to help users to enjoy body stimulation and 2 big electrode pads in Electrode Silicon Area for feet placed on the main unit to help users to enjoy sole stimulation.
The electronic stimulatory module has the operating elements of ON/OFF Switch, Display screen, Mode Selection key and Intensity Modification keys.
The models AST-300A and AST-300W have 9 buttons which is more than other models. Compared with other models, the "Time+" and "Time-" buttons are used to adjust the treatment time.
The LCD display screen can show selected mode, output intensity of body and/or sole, and time remaining of an application model. The device is equipped with accessories of electrode pads, electrode wire, adapter, remote controller. The electrode wire is used to connect the pads to the main unit; the adapter wire is used to connect the adapter to the device. The electrode pads are complying with the biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization), are interchangeable.
This document is a 510(k) Summary for an Electronic Muscle Stimulator, demonstrating substantial equivalence to a predicate device. It is not a report for an AI-powered medical device and therefore does not contain information typically found in such reports regarding acceptance criteria for AI performance, specific studies with test sets, expert ground truth establishment, MRMC studies, or training set details.
Based on the provided text, here's what can be extracted, and where limitations exist:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state "acceptance criteria" in the context of AI performance metrics (like sensitivity, specificity, AUC). Instead, it compares the subject device's specifications to those of a predicate device to demonstrate substantial equivalence. The acceptance is implicitly shown by meeting the same or similar specifications as the already cleared predicate device, and demonstrating that any differences do not raise new safety or effectiveness issues.
Here is a table based on the "Elements of Comparison" between the Subject Device and Predicate Device, which serves as the "performance" for this type of device:
| Acceptance Criteria (e.g., Predicate Device Performance) | Reported Device Performance (Subject Device) | Remark |
|---|---|---|
| Device Name and Model: Health Expert Electronic Stimulator Model: AST-300F, AST-300H, AST-300J | Electronic Muscle Stimulator Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W | -- |
| 510(k) Number: K190673 | Applying (K211736) | -- |
| Intended Use (PMS): To stimulate healthy muscles to improve and facilitate muscle performance. | Same | SE (Substantially Equivalent) |
| Intended Use (TENS): Temporary relief of pain associated with sore and aching muscles in shoulder, waist, back, neck, arm, leg, foot due to strain from exercise or normal household work activities by applying current to stimulate nerve. | Same | SE |
| Power Source(s): Adaptor Input: 100-240Vac, 50-60Hz, 0.1A; Output: 5Vdc, 1A; Unit Input: 5Vdc, 1A | Same | SE |
| Method of Line Current Isolation: Type BF Applied Part | Same | SE |
| Patient Leakage Current (NC): AC: 54.5 µA, DC: 0 µA | AC: 54.5 µA, DC: 0.5 µA | SE |
| Patient Leakage Current (SFC): AC: 120.0 µA, DC: 0 µA | AC: 120.0 µA, DC: 0.6 µA | SE |
| Average DC current through electrodes (device on but no pulses): |
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).